Solita RegProof®

We have developed a comprehensive way to measure the maturity of an organisation in developing regulated medical devices.

How is it carried through?

We’ll interview your people to find out how your organisation is performing in different dimensions (ways of working, regulatory performance, product management, development process, quality assurance, risk management).

What can you expect from it?

You’ll get a report that will score each of the 6 dimensions and suggestions on how to improve. This will help you to focus on the most essential areas. 

Concepting is a critical first step in the journey of developing a medical device. This phase transforms your idea into a tangible prototype, ensuring that it effectively addresses the identified problem and fits the needs of its users. It’s not just about creating a model; it’s about validating your vision in a way that sets a strong foundation for the development process.

This is the ideal time to outline a roadmap for compliance with regulatory requirements (e.g., MDR, FDA) and classify the device appropriately.

With a well-thought-out concept, the development path becomes clearer, faster, and less stressful. 

In this phase, we take full responsibility for turning your concept into a fully compliant and functional product, ensuring it meets all regulatory requirements and is audit-ready for a notified body.

Strategic partnership: You can outsource the design & development of your solution on a QMS level to us. Acting as your trusted partner, we will utilise our RegProof® service model to bring together regulatory expertise, technical innovation, and user-centered design.

We have invested a lot of time and effort to make our RegProof® service model and processes efficient and agile with fine-tuned workflows, a high level of automation in document and evince generation so that we can have fast release cycles without stress.

Speed without compromise: Our approach is optimised to get your solution to the finish line in record time, without sacrificing quality or compliance.

This improved efficiency has been also validated in real life. One of our customers asked us to help them, as with their existing process it took 6 months to get a new release published after the actual software was ready. We stepped in and guided them to make the process more agile and efficient: nowadays they can have a new release every month.

Our support doesn’t end when your product enters the market. We offer comprehensive, ISO 13485-certified lifecycle services to ensure your solution remains impactful and compliant throughout its lifespan.

Key elements of our lifecycle services include:

• Post-market surveillance: Monitoring performance, collecting real-world data, and addressing regulatory requirements to ensure safety and effectiveness.
• Continuous improvement: Updating and enhancing your product to adapt to new regulations, technologies, and user needs.
• Risk management: Proactively identifying and mitigating risks to maintain compliance and minimise disruptions.
• Seamless maintenance: Handling updates, security patches, and performance improvements with minimal impact on users.

With our lifecycle services, your product remains reliable, relevant, and ready to make a lasting impact in healthcare.